|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of Oklahoma |
|---|---|
| Information provided by: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00717574 |
Purpose
The study hypothesize that adding 60% nitrous oxide to a steady state sevoflurance or propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant level of surgical stimulus
| Condition | Intervention |
|---|---|
|
Deep Sedation Anesthesia, General |
Drug: nitrous oxide Device: BIS Monitor Device: Entropy Monitor |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Addition of Nitrous Oxide to a Sevoflurane or Propofol Based Anesthetic and Its Effects on Depth of Anesthesia Indices (N20) |
| Estimated Enrollment: | 32 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Sevoflurane based general anesthesia
|
Drug: nitrous oxide
Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
Device: BIS Monitor
BIS Monitor electrodes placed on forehead
Device: Entropy Monitor
Entropy monitor electrodes placed to forehead
|
|
2: Active Comparator
Propofol based general anesthesia
|
Drug: nitrous oxide
Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
Device: BIS Monitor
BIS Monitor electrodes placed on forehead
Device: Entropy Monitor
Entropy monitor electrodes placed to forehead
|
Nitrous oxide is a widely used general anesthetic pas. It is often used in addition to a second, more potent agent. BIS and Entropy are depth of anesthesia monitors in clinical use. There are conflicting reports about the usefulness of these monitors. When nitrous oxide is used as a part of the anesthetic regimen. While some studies demonstarte a decrease in BIS and Entropy study aims to investigate the effects of adding nitrous oxide to a sevoflurane to propofol based anesthetic on BIS and Entropy indices.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mehmet S. Ozcan, M.D. | 405-271-4351 | mehmet-ozcan@ouhsc.edu |
| Contact: Qaiser Khan, M.D., M.P.H. | 405-271-4351 | qaiser-khan@ouhsc.edu |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Recruiting |
| oklahoma, Oklahoma, United States, 73152 | |
| Contact: Ozcan, M.D 405-271-4351 | |
| Contact: QAISER S KHAN, M.D.,M.P.H 405-271-8001 qaiser-khan@ouhsc.edu | |
| Principal Investigator: Mehmet Ozcan, M.D | |
| Principal Investigator: | Mehmet S Ozcan, M.D. | University of Oklahoma |
More Information
| Responsible Party: | OUHSC ( Dr.Mehmet Ozcan Assistant Professor ) |
| Study ID Numbers: | 13800 |
| Study First Received: | July 9, 2008 |
| Last Updated: | January 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00717574 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
depth of sedation nitrous oxide general anesthesia anesthesia indices |
|
Anesthetics, Inhalation Anesthetics, General Analgesics, Non-Narcotic Nitrous Oxide Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Analgesics Propofol Sevoflurane |
|
Nitrous Oxide Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pharmacologic Actions Anesthetics, Inhalation Analgesics, Non-Narcotic |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |
